|
Difficulty walking or bending and can barely walk without pain [gait disturbance].Difficulty walking or bending [joint range of motion decreased].Heat in the knee area [administration site joint warmth].Knee pain [arthralgia].Immense knee swelling [joint swelling].Case narrative: case (b)(4) is a serious spontaneous case received from a consumer via regulatory authority in united states.This report concerns a female of an unknown age who experienced difficulty walking or bending and can barely walk without pain, heat in the knee area, knee pain, immense knee swelling during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration 2 ml, for pain in knee from 2020 to 2020.Device lot number unknown.The patient experienced immense knee swelling, heat in the area and pain after receiving final euflexxa injection.The patient had difficulty walking or bending.After 12 weeks now, still no progress, there was no pain knee before euflexxa except when running.Now the patient could barely walk without pain.The reason for euflexxa use was reported as pain in knee when running, the beginning of arthritis.The patient was disabled or suffered permanent damage due to difficulty walking or bending and can barely walk without pain.Action taken with euflexxa was not applicable.At the time of this report, the outcome of difficulty walking or bending and can barely walk without pain was not recovered, the outcome of difficulty walking or bending was not recovered, the outcome of heat in the knee area was not recovered, the outcome of knee pain was not recovered, the outcome of immense knee swelling was not recovered.The patient's med hist/procedure was significant for pain in knee when running (from unknown start date to unknown stop date).No concomitant medication was reported.The events difficulty walking or bending and can barely walk without pain were reported as serious.The events heat in the knee area, knee pain, immense knee swelling were reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = mw5097175.This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the medical device directive/ because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.
|
